Effect of Long Term Cocoa Flavanol Intake on Blood Pressure and Platelet Function in Healthy Adults, Part 1

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Mars Cocoa Extract Capsules

• Registration Number: NCT02447770
• Lead Sponsor: University of California, Davis

Brief Summary

Flavanols are plant-derived compounds commonly present in the human diet. Examples of flavanol-containing foods and beverages are apples, chocolate, tea, wine, berries, pomegranate and nuts. The consumption of flavanol-containing foods and beverages has been associated with improvements in cardiovascular health. In this study, the investigators hope to learn more about the effects of the consumption of increasing amounts of cocoa flavanols on blood pressure, platelet function and other metabolic parameters in healthy humans. This study was followed by a second study that aimed at investigating the effects of long term consumptions of cocoa flavanols on blood pressure, platelet function and other metabolic parameters in healthy humans.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Study First Submitted: 2015-05-15
• Study First Submitted QC: 2015-05-18
• Study First Posted: 2015-05-19
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-26
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• 30-55 years old
• A normal blood chemistry and liver function
• BMI < 30 kg/m2
• previously consumed cocoa and peanut products, with no adverse reactions

Read More

Exclusion Criteria

• A history of cardiovascular disease, stroke, hypertension, renal, hepatic, or thyroid disease, GI tract disorders, previous GI surgery, metabolic syndrome, diabetes, taking cholesterol-lowering medication, hormone replacement therapy, antioxidant supplements, on aspirin therapy or taking anticoagulants, or on a medically prescribed diet.
• Allergies to nuts, cocoa and chocolate products
• Vegetarian, Vegan, food faddists, individuals using non-traditional diets, on a weight loss diet or using herbal dietary supplements

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cocoa Flavanol intake escalation	Mars Cocoa Extract Capsules	Ingestion of increasing number of capsules containing Mars Cocoa Extract manufactured by the Cocoapro® process (500 mg of cocoa flavanols/capsule) during 6 weeks followed by a 2 week of washout (no capsule intake)

Primary Outcome Measures

Name	Time	Method
Change in blood pressure	Baseline (day 0) and 14, 28, 42 and 56 days after intervention	Blood pressure will be measured using standard techniques.
Change in platelet function	Baseline and 14, 28, 42 and 56 days after intervention	Platelet function will be determined using the PFA-100® analyzer (Dade Behring International, Miami, FL) with collagen-epinephrine (CEPI)- and collagen-ADP (CADP) stimulation.
Change in metabolic parameters in blood	Baseline (day 0) and 14, 28, 42 and 56 days after intervention	Metabolic parameters determined in blood included: comprehensive metabolic panel, liver panel and cell blood counting.

Secondary Outcome Measures

Name	Time	Method
Change in plasma concentration of cocoa flavanol metabolites	Baseline (day 0) and 14, 28, 42 and 56 days after intervention	Cocoa flavanol metabolites in plasma include: structurally related (-)-epicatechin metabolites and 5-(3,4-dihydroxyphenyl)-4-valerolactone metabolites
Change in plasma concentration of methylxanthines	Baseline (day 0) and 14, 28, 42 and 56 days after intervention	Methylxanthines determined in plasma include: caffeine, theobromine, paraxanthine and theophylline

Trial Locations

Locations (1)

Ragle Human Nutrition Research Center, Department of Nutrition at UC Davis; 🇺🇸 Davis, California, United States